BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON METAL BACKED

    MDR report key: 2091363 · Received May 5, 2011

    Report

    Report Number
    2249697-2011-00659
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    MR (B)(6), POSITION UNKNOWN, REPORTED VIA OUR SALES REP (B)(6) THAT DEVICE BROKE WHILE DRILLING. FURTHER HE REPORTED THAT SURGERY WAS CONTINUED WITH ALTERNATIVE AND FINISHED WITHOUT DELAY WITH DESIRED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON METAL BACKED INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other